Associate Manager
AssociateManager-QualityAssurance
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optimal for Mid candidates.
“Associate Manager - Quality Assurance at Associate Manager. Skills: Quality Assurance, Technology transfers, Validations. Review, approval of change controls. Ensure compliance of SOPs”
What You'll Achieve.
ensure the compliance of SOPs; ensure validation life cycle; meet regulatory expectations; meet global regulatory and Pfizer quality standards
Industry & Context.
Proactive approach to problem-solving
What They're Looking For.
Must Have
B. Pharm/ M. Pharm /M. Sc, 6-7 years of experience in sterile injectable Quality Assurance /Technology transfers / validations, Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards, critical thinking skills, Ability to work effectively within own team and interdepartmental teams, Good working knowledge of Microsoft Excel and Word, Proactive approach to problem-solving
What You'll Do.
approval of change controls
Ensure compliance of SOPs
Review and approval of validation protocols
Support production related documents review
Ensuring Zero Defect Technology transfer
Quality Support and review of Scale-up
Reviews of Process validation protocols
Review of Optimization Report
Responsible to manage New Product Introduction
Review and approval of Project validation protocols
Review of Analytical Method Transfer
Continuous improvement of templates
Evaluate and review commercial drug batches
Approve change control activities
Independently assess Change Control activities
Investigate and document Quality Assurance deviations
Ensure regulatory compliance with GxP
Provide Quality Review and oversight
How You'll Work.
Team & Collaboration
Ability to work effectively within own team and interdepartmental teams
Process & Methodology
New Product Introduction (NPI) projects
Full Job Description
**What You Will Achieve** In this role, you will: * Review , approval of change controls ensure the compliance of SOPs related to technology transfer . * Review and approval of validation protocols , PRQs and PR’s to ensure validation life cycle . * Support production related documents review and approvals. * Ensuring Zero Defect Technology transfer for new product transfers into site. * Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations. * Reviews of Process validation protocols and reports to meet regulatory expectations. * Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data. * Responsible to manage New Product Introduction (NPI) projects. * Review and approval of Project validation protocols, QRM’s, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports. * Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned in the other transfer sites. * Continuous improvement of templates for presentations, timelines, trackers, and other tools. * Evaluate and review commercial drug batches to ensure compliance with established specifications. * Approve change control activities to maintain compliance with configuration management policies. * Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. * Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. * Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. **Here Is What You Need**(Minimum Requirements) * B. Pharm/ M. Pharm /M. Sc * Experience: 6-7 years of experience in sterile injectable Quality Assurance /Technology transfers / vali
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